Phase 2, Single Arm, Open Label Study of Folotyn in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies

Inclusion Criteria:

1. Patient is diagnosed with hematological malignancies including PTCL and CTCL and are
eligible for treatment with a dose of 30 mg/m^2

2. Patient is at least 18 years of age

3. Patient has been informed of the investigational nature of this study and has given
written Informed Consent and is able to adhere to dosing and visit schedules and meet
all study requirements

4. Patient has recovered from the toxic effects of prior therapy, and is at least 30 days
from the most recent cytotoxic therapy, prior to enrollment

5. Patient has adequate hematologic, hepatic, and renal function as defined by:

- ANC ≥1000/µL

- Platelet count ≥100,000/µL

- Total bilirubin ≤1.5 mg/dL

- Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT),
alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and
gamma-glutamyltransferase (GGT) ≤2.5 xupper limit of normal (ULN) (AST/ALT/GGT ≤5
xULN if documented hepatic involvement with lymphoma)

- Creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥50 mL/min

6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

7. Females of childbearing potential are to agree to practice a medically acceptable
contraceptive regimen (including a barrier method) from study treatment initiation
until at least 30 days after the last administration of Folotyn or leucovorin,
whichever is last, and are to have a negative urine beta human chorionic gonadotropin
(β-HCG) pregnancy test within 14 days prior to the first day of study treatment.
Females who are postmenopausal for at least 1 year (defined as >12 months since last
menses) or are surgically sterilized do not require this test

8. Male patients are to agree to use a barrier method of contraception from study
treatment initiation until at least 90 days after the last administration of Folotyn

Exclusion Criteria:

1. Patient has congestive heart failure Class III/IV according to the New York Heart
Association (NYHA) Functional Classification

2. Patient has uncontrolled hypertension

3. Patient has known, uncontrolled human immunodeficiency virus (HIV)-positive diagnosis

4. Patient has symptomatic central nervous system (CNS) metastases or lesions for which
treatment is required. Patients who received prophylactic CNS treatment are eligible

5. Patient has an active uncontrolled infection, underlying medical condition, or other
serious illness that would impair the ability of the patient to receive protocol
treatment

6. Patient has had major surgery within 14 days prior to enrollment

7. Patient has used any investigational drugs, biologics, or devices within 14 days prior
to study treatment or plans to use any of these during the course of the study

8. Patient has had previous exposure to Folotyn within 6 months of study enrollment

9. Patient is pregnant or breast-feeding